Impacts d'une exposition à l'aripiprazole au cours de la période embryonnaire (cohorte prospective multicentrique)

LYON1-BU Santé (693882101) / SudocSudocFranceF

Efficacy of Baclofen on Abstinence and Craving in Alcohol-dependent Patients: a Meta-analysis of Randomized Controlled Trials

Purpose. We conducted a meta-analysis in order to estimate the efficacy of baclofen on the maintenance of abstinence and the decrease of craving in alcohol-dependent patients. Methods. All randomized controlled clinical trials assessing baclofen for at least four weeks’ treatment duration versus placebo or other comparators were included. The primary outcome measure was the percentage of patients who had not consumed alcohol at the end of the treatment. Measures of cumulative abstinence and indexes of craving were also assessed. Results. Compared to placebo, baclofen was associated with a significant increase of 179% in the percentage of abstinent patients at the end of the trial, without heterogeneity. For secondary outcome measures, based on a random-effect model, no significant effect of baclofen was observed compared to placebo. Conclusions. Our meta-analysis brings weak support towards an efficacy of low dosages of baclofen on the maintenance of abstinence in alcohol-dependent patients

Comment on “Assessment of the Utility of Social Media for Broad-Ranging Statistical Signal Detection in Pharmacovigilance: Results from the WEB-RADR Project”

International audienc

Use of Social Media for Pharmacovigilance Activities: Key Findings and Recommendations from the Vigi4Med Project

International audienceThe large-scale use of social media by the population has gained the attention of stakeholders and researchers in various fields. In the domain of pharmacovigilance, this new resource was initially considered as an opportunity to overcome underreporting and monitor the safety of drugs in real time in close connection with patients. Research is still required to overcome technical challenges related to data extraction, annotation, and filtering, and there is not yet a clear consensus concerning the systematic exploration and use of social media in pharmacovigilance. Although the literature has mainly considered signal detection, the potential value of social media to support other pharmacovigilance activities should also be explored. The objective of this paper is to present the main findings and subsequent recommendations from the French research project Vigi4Med, which evaluated the use of social media, mainly web forums, for pharmacovigilance activities. This project included an analysis of the existing literature, which contributed to the recommendations presented herein. The recommendations are categorized into three categories: ethical (related to privacy, confidentiality, and follow-up), qualitative (related to the quality of the information), and quantitative (related to statistical analysis). We argue that the progress in information technology and the societal need to consider patients' experiences should motivate future research on social media surveillance for the reinforcement of classical pharmacovigilance

Pharmacology and social media: Potentials and biases of web forums for drug mention analysis-case study of France

International audienceThe aim of this study is to analyze drug mentions in web forums to evaluate the utility of this data source for drug post-marketing studies. We automatically annotated over 60 million posts extracted from 21 French web forums. Drug mentions detected in this corpus were matched to drug names in a French drug database (Theriaque®). Our analysis showed that a high proportion of the most frequent drug mentions in the selected web forums correspond to drugs that are usually prescribed to young women, such as combined oral contraceptives. The most mentioned drugs in our corpus correlated weakly to the most prescribed drugs in France but seemed to be influenced by events widely reported in traditional media. In this article, we conclude that web forums have high potential for post-marketing drug-related studies, such as pharmacovigilance, and observation of drug utilization. However, the bias related to forum selection and the corresponding population representativeness should always be taken into account

Chocs anaphylactiques d’origine médicamenteuse : sous-notification et PMSI

Objectif. Évaluer l’intérêt d’une recherche dans la base de données du programme de médicalisation des systèmes d’information (PMSI) pour l’identification des cas de chocs anaphylactiques ou anaphylactoïdes (CA) médicamenteux. Méthodes. Extraction des séjours de patients hospitalisés au centre hospitalier universitaire de Saint-Étienne du 1er juillet 2009 au 30 juin 2012 correspondant aux cinq codes de la classification internationale des maladies suivants : T88.6, T88.2, J39.3, T80.5 et T78.2. Résultats. Sur 89 séjours répondant aux critères, 40 (45 %) correspondaient bien à un CA parmi lesquels 16 cas avaient été déclarés au centre régional de pharmacovigilance. Le code peu spécifique « choc anaphylactique sans précision (T78.2) » était codé pour 57,5 % des cas. Conclusion. L’étude confirme l’intérêt de l’utilisation du PMSI comme outil de veille, en complément de la notification spontanée. Cependant la qualité du codage et sa faible précision entraînent une perte de temps conséquente avec le retour au dossier médical

A pilot study of the Vigi4MED project: comparison of adverse drug reactions (ADRs) of duloxetine between patients' forum posts and the French pharmacovigilance database (FPVD)

International audienc

Evaluating Twitter as a complementary data source for pharmacovigilance

International audienc

A pilot study of the Vigi4MED project: comparison of adverse drug reactions (ADRs) of duloxetine between patients' forum posts and the French pharmacovigilance database (FPVD)

International audienc

Adverse Drug Reaction Identification and Extraction in Social Media: A Scoping Review

International audienceBackground: The underreporting of adverse drug reactions (ADRs) through traditional reporting channels is a limitation in the efficiency of the current pharmacovigilance system. Patients' experiences with drugs that they report on social media represent a new source of data that may have some value in postmarketing safety surveillance.Objective: A scoping review was undertaken to explore the breadth of evidence about the use of social media as a new source of knowledge for pharmacovigilance.Methods: Daubt et al's recommendations for scoping reviews were followed. The research questions were as follows: How can social media be used as a data source for postmarketing drug surveillance? What are the available methods for extracting data? What are the different ways to use these data? We queried PubMed, Embase, and Google Scholar to extract relevant articles that were published before June 2014 and with no lower date limit. Two pairs of reviewers independently screened the selected studies and proposed two themes of review: manual ADR identification (theme 1) and automated ADR extraction from social media (theme 2). Descriptive characteristics were collected from the publications to create a database for themes 1 and 2.Results: Of the 1032 citations from PubMed and Embase, 11 were relevant to the research question. An additional 13 citations were added after further research on the Internet and in reference lists. Themes 1 and 2 explored 11 and 13 articles, respectively. Ways of approaching the use of social media as a pharmacovigilance data source were identified.Conclusions: This scoping review noted multiple methods for identifying target data, extracting them, and evaluating the quality of medical information from social media. It also showed some remaining gaps in the field. Studies related to the identification theme usually failed to accurately assess the completeness, quality, and reliability of the data that were analyzed from social media. Regarding extraction, no study proposed a generic approach to easily adding a new site or data source. Additional studies are required to precisely determine the role of social media in the pharmacovigilance system